WO2005102354A1 - Utilisation de ciclesonide pour le traitement des maladies respiratoires chez des patients fumeurs - Google Patents

Utilisation de ciclesonide pour le traitement des maladies respiratoires chez des patients fumeurs Download PDF

Info

Publication number
WO2005102354A1
WO2005102354A1 PCT/EP2005/051718 EP2005051718W WO2005102354A1 WO 2005102354 A1 WO2005102354 A1 WO 2005102354A1 EP 2005051718 W EP2005051718 W EP 2005051718W WO 2005102354 A1 WO2005102354 A1 WO 2005102354A1
Authority
WO
WIPO (PCT)
Prior art keywords
ciclesonide
patient
dion
oxy
composition
Prior art date
Application number
PCT/EP2005/051718
Other languages
English (en)
Inventor
Wilhelm Wurst
Thomas Bethke
Renate Engelstaetter
Original Assignee
Altana Pharma Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Altana Pharma Ag filed Critical Altana Pharma Ag
Priority to JP2007508906A priority Critical patent/JP2007533706A/ja
Priority to US11/578,294 priority patent/US20070134165A1/en
Priority to CA2563556A priority patent/CA2563556C/fr
Priority to AU2005235384A priority patent/AU2005235384B2/en
Priority to EP05742781A priority patent/EP1740188A1/fr
Publication of WO2005102354A1 publication Critical patent/WO2005102354A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/04—Drugs for disorders of the respiratory system for throat disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/16—Central respiratory analeptics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents

Definitions

  • This invention relates to a new method of treatment of respiratory diseases, in particular the treatment of smoking asthmatic patients.
  • ICS Inhaled corticosteroids
  • US 5482934 discloses pregna-1,4-diene-3,20-dione-16-17-acetal-21 esters and their use in the treatment of inflammatory conditions.
  • the compounds have the general structure:
  • Cicle- sonide is the INN for a compound of formula I in which R1 is cyclohexyl and R2 is isobutanoyi with the chemical name [11 ⁇ ,16 ⁇ (R)]-16,17-[(Cyclohexylmethylene)bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxo- propoxy)pregna-1,4-diene-3,20-dione.
  • Ciclesonide is a novel inhaled corticosteroid for asthma treatment, which is undergoing clinical evaluation. Ciclesonide has very low affinity for the glucocorticosteroid receptor but is readily converted to the active metabolite desisobutyryl-ciclesonide by esterases in the lung to provide local activity in the target organ. This activation occurs by ester cleavage at the C21 position of ciclesonide. The affinity of desisobutyryl-ciclesonide to the glucocorticosteroid receptor is approximately 100 times higher than that of ciclesonide. Ciclesonide is only moderately absorbed after oral administration and has low systemic activity.
  • Concentration of the drug in the lungs is high and metabolism by liver oxidases is very high, giving the drug a low plasma half-life.
  • Systemic activity of ciclesonide is three times lower than that of budesonide, but anti-inflammatory activity is higher for the former.
  • Subject of the invention is therefore a method for treating a respiratory disease in a patient, which patient is a smoking patient and the method comprising administering to the patient a therapeutically effective and pharmacologically tolerable dose of a composition containing ciclesonide, a pharmaceutically acceptable salt, solvates or physiologically functional derivative thereof.
  • Ciclesonide (herein also referred to as active ingredient) is the INN for an active compound having the chemical name [11 ⁇ ,16 -(R)]-16,17-[(cyclohexylmethylene)bis(oxy)]-11-hydroxy-21-(2-methyl-1- oxopropoxy)pregna-1,4-diene-3,20-dione.
  • Ciclesonide and its preparation are described in US 5482934.
  • the name ciclesonide also includes solvates of ciclesonide, physiologically functional derivatives of ciclesonide or solvates thereof.
  • the 21 -hydroxy compound has the chemical name 16 ⁇ ,17-(22R,S)-cyclohexylmethylenedioxy-11 ⁇ ,21-dihydroxypregna-1,4-diene- 3,20-dione. This compound and its preparation are disclosed in WO 94/22899.
  • the name "ciclesonide 1 ' is understood as meaning not only the pure R epimer of the compound [11 ⁇ ,16 ⁇ ] 16, 17-[(cyclohexylmethylene)bis(oxy)]-11 -hydroxy-21 -(2-methyl-1 -oxopropoxy)pregna- 1,4-diene-3,20-dione but also R/S epimer mixtures in any desired mixing ratio (that is the compounds [11 ⁇ ,16 ⁇ (R)]-16, 17-[(cyclohexylmethylene)bis(oxy)]- 11 -hydroxy-21 -(2-methyl-1 -oxopropoxy)pregna ⁇ 1 ,4diene3,20-dione and [11 ⁇ ,16 (S)]-16, 17-[(cyclohexylmethylene)bis(oxy)]-11 -hydroxy-21 - (2-methyl1-oxopropoxy)pregna-1,4-diene-3,20-dione), those being preferred which essentially consist of R epimers. According to the compounds [11
  • ciclesonide is preferably administered to the patient at a daily dose range of from 20 to 1600 ⁇ g.
  • Exemplary doses in connection with the invention comprise 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 320 ⁇ g ciclesonide.
  • the dose comprises 40, 80, 160 or 320 ⁇ g ciclesonide.
  • the dose is preferably a daily dose and administered once or twice daily, preferably once daily.
  • a once daily dose may be administered any time of the day, e.g. in the morning or preferably in the evening.
  • the administration of a daily dose of ciclesonide in the range of from 20 to 320 ⁇ g is preferably part of a continuous treatment regimen, preferably a treatment period of more than one day, particularly preferably more than one week, e.g. a two week treatment period, a one month treatment period, a one year treatment period or a life long treatment period.
  • the patient in connection with the invention is a smoker.
  • Smoker in connection with the invention preferably refers to a patient with a smoking history of less than 10 pack per year of cigarettes or less than two pipe packs per years.
  • Smoker in connection with the invention also refers to a patient, which has quit smoking (ex-smoker).
  • ex-smokers refers to a smoker with a smoking history of less than 10 pack per year of cigarettes or less than two pipe packs per years and at least three months of smoking abstinence.
  • Ciclesonide has been described for use in the treatment of respiratory diseases. Therefore, formulations of ciclesonide have use in the prophylaxis and treatment of clinical conditions for which a glucocorticosteroid is indicated. Such conditions include diseases associated with reversible airways obstruction such as asthma, nocturnal asthma, exercise-induced asthma, chronic obstructive pulmonary diseases (COPD) (e. g. chronic and whez bronchitis, emphysema), respiratory tract infection and upper respiratory tract disease (e. g. rhinitis, such as allergic and seasonal rhinitis).
  • COPD chronic obstructive pulmonary diseases
  • the respiratory disease in connection with the invention refers to asthma or chronic obstructive pulmonary disease.
  • Asthma in connection with invention preferably refers to mild to severe asthma/persistent asthma.
  • compositions comprising ciclesonide include those suitable for oral, parenteral including subcutaneous, intradermal, intramuscular, intravenous and intraaarticular, intranasal, inhalation (including fine particle dusts or mists which may be generated by means of various types of metered dose pressurised aerosols, nebulisers or insufflators), rectal and topical (including dermal, buccal, sublingual and intraocular administration) although the most suitable route may depend upon for example the condition and disorder of the recipient.
  • the formulations may conveniently be presented in unit dosage form and may be prepared by any of the methods well known in the art of pharmacy.
  • All methods include the step of bringing the active ingredients into association with the carrier, which constitutes one or more accessory ingredients/excipients.
  • the formulations are prepared by uniformly and intimately bringing into association the active ingredient with liquid carriers or finely divided solid carriers or both and then, if necessary, shaping the product into the desired formulation.
  • ciclesonide is provided in a form suitable for inhalation.
  • Formulations for inhalation include powder compositions, which will preferably contain lactose, and spray compositions which may be formulated, for example, as aqueous solutions or suspensions or as aerosols delivered from pressurised packs, with the use of a suitable propellant, e. g. 1, 1, 1, 2-terafluorethane, 1, 1, 1, 2, 3, 3, 3-heptafluoropropane, carbon dioxide or other suitable gas.
  • a suitable propellant e. g. 1, 1, 1, 2-terafluorethane, 1, 1, 1, 2, 3, 3, 3-heptafluoropropane, carbon dioxide or other suitable gas.
  • a class of propellants which are believed to have minimal ozone-depleting effects in comparison to conventional chlorofluorocarbons comprise hydrofluorocarbons and a number of medicinal aerosol formulations using such propellant systems are disclosed in, for example, EP 0372777, W091/04011, W091/11173, W091/11495, W091/14422, W093/11743, and EP-0553298.
  • These applications are all concerned with the preparation of pressurised aerosols for the administration of medicaments and seek to overcome problems associated with the use of this new class of propellants, in particular the problems of stability associated with the pharmaceutical formulations prepared.
  • the applications propose, for example, the addition of one or more of excipients such as polar cosolvents or wetting agents (e.g.
  • alcohols such as ethanol
  • alkanes such as ethanol
  • dimethyl ether such as ethanol
  • surfactants including fluorinated and non-fluorinated surfactants, carboxylic acids such as oleic acid, polyethoxylates etc.
  • bulking agents such as a sugar
  • WO02/30394 surfactants
  • vehicles such as cromoglicic acid and/or nedocromil which are contained at concentrations, which are not therapeutically and prophylactically active (see WO00/07567).
  • the active ingredients should be micronised so as to permit inhalation of substantially all of the active ingredients into the lungs upon administration of the aerosol formulation, thus the active ingredients will have a mean particle size of less than 100 microns, desirably less than 20 microns, and preferably in the range 0.7 to 10 microns, for example, 1 to 5 microns.
  • WO 98/52542 is related to pharmaceutical compositions comprising a therapeutically effective amount of ciclesonide or a related compound and a hydrofluorocarbon propellant, preferably selected from 1,1,1,2-tetrafluoroetha ⁇ e, 1,1,1,2,3,3,3-heptafluoropropane and a mixture thereof, and cosolvent, preferably ethanol, in an amount effective to solubilize ciclesonide and optionally a surfactant.
  • a hydrofluorocarbon propellant preferably selected from 1,1,1,2-tetrafluoroetha ⁇ e, 1,1,1,2,3,3,3-heptafluoropropane and a mixture thereof
  • cosolvent preferably ethanol
  • ciclesonide is administered in a composition according to W098/52542.
  • such solution formulation provides a fine particle spray, yielding high pulmonary deposition in central and peripheral regions.
  • Ciclesonide is generally present in the formulation at a concentration, which allows administration of a dose of from 20 to 1600 ⁇ g.
  • Such formulation generally comprises ethanol in an amount effective to solubilize the ciclesonide.
  • the propellant preferably includes a hydrofiuoroalkane, in particular Propellant 134a, Propellant 227 or a mixture thereof. In the case of a mixture the ratio of Propellant 134a to Propellant 227 is generally in a range from 75:25 w/w to 25:75 w/w.
  • the formulations may contain surfactant such as oleic acid, but may be also free of surfactant.
  • the formulations are preferably free of other excipients.
  • the formulations may be manufactured by preparing a drug concentrate of the active ingredients with ethanol and adding this concentrate to the pre-chilled propellant in a batching vessel.
  • a solution of the ciclesonide in the cosolvent is added to the prechilled propellant in a batching vessel.
  • the resulting formulation is filled into vials.
  • the formulations may be prepared by adding the required quantity of active ingredient into an aerosol vial, crimping a valve on the vial and introducing a pre-mixed blend of propellant and ethanol through the valve.
  • the vial is placed in an ultrasonic bath to ensure solubilisation of ciclesonide.
  • compositions for aerosol delivery contain the active ingredient in particulate form, and 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane or mixtures thereof as propellant.
  • Such formulation generally comprises from 0.01 to 5% (w/w relative to the total weight of the formulation) of polar cosolvent, in particular ethanol. In a preferred embodiment no or less than 3% w/w of polar cosolvent, in particular ethanol is contained.
  • compositions for aerosol delivery consist of particulate active ingredient, and 1, 1, 1 , 2-tetrafluoroethane, 1 , 1 , 1 , 2, 3, 3, 3-heptafluorpropane or mixtures thereof as propellant and optionally a surfactant (preferably oleic acid).
  • a surfactant preferably oleic acid
  • the ratio of Propellant 134a to Propellant 227 is generally in a range from 75:25 w/w to 25:75 w/w.
  • the formulations may be prepared by adding the required quantity of active ingredient into an aerosol vial, crimping a valve on the vial and introducing propellant or optionally a pre-mixed blend of propellant and optionally the cosolvent and surfactant through the valve.
  • Canisters generally comprise a container capable of withstanding the vapour pressure of the propellant, such as plastic or plastic-coated glass bottle or a metal can, for example an aluminium can which may optionally be anodised, lacquer-coated and/or plastic-coated, which container is closed with a metering valve.
  • Canisters may be coated with a fluorocarbon polymer as described in WO 96/32150, for example, a co-polymer of polyethersulphone (PES) and polytetrafluoroethylene (PTFE). Another polymer for coating that may be contemplated is FEP (fluorinated ethylene propylene).
  • PES polyethersulphone
  • PTFE polytetrafluoroethylene
  • the metering valves are designed to deliver a metered amount of the formulation per actuation and incorporate a gasket to prevent leakage of propellant through the valve.
  • the gasket may comprise any suitable elastomeric material such as for example low density polyethylene, chlorobutyl, black and white butadiene-acrylonitrile rubbers, butyl rubber and neoprene.
  • Thermoplastic elastomer valves as described in W092 11190 and valves containing EPDM rubber as described in W095/02650 may be suitable. Suitable valves are commercially available from manufacturers well known in the aerosol industry, for example, from Valois, France (eg. DF10, DF30, DF60), Bespak pic, UK (eg. BK300, BK356, BK357) and 3M-Neotechnic Ltd, UK (eg. Spraymiser).
  • Valve seals especially the gasket seal and also the seals around the metering chamber, can be manufactured of a material, which is inert to and resists extraction into the contents of the formulation, especially when the contents include ethanol.
  • Valve materials especially the material of manufacture of the metering chamber, can be manufactured of a material, which is inert to and resists distortion by contents of the formulation, especially when the contents include ethanol.
  • Particularly suitable materials for use in manufacture of the metering chamber include polyesters eg polybutyleneterephthalate (PBT) and acetals, especially PBT.
  • Materials of manufacture of the metering chamber and/or the valve stem may desirably be fluorinated, partially fluorinated or impregnated with fluorine containing substances in order to resist drug deposition.
  • Valves which are entirely or substantially composed of metal components (eg Spraymiser, 3M- Neotechnic), are especially preferred for use according to the invention.
  • metal components eg Spraymiser, 3M- Neotechnic
  • Intranasal sprays or nasal drops may be formulated with aqueous or non-aqueous vehicles with or without the addition of agents such as thickening agents, buffer salts or acid or alkali to adjust the pH, isotonicity adjusting agents, preservatives or anti-oxidants.
  • aqueous formulations for ciclesonide for application to mucosa are for example disclosed in WO01/28562 and WO01/28563.
  • the pharmaceutical formulation comprising the ciclesonide in as a dry powder, i.e. ciclesonide is present in a dry powder comprising finely divided ciclesonide optionally together with a finely divided pharmaceutically acceptable carrier, which is preferably present and may be one or more materials known as carriers in dry powder inhalation compositions, for example saccharides, including monosaccharides, disaccharides, polysaccharides and sugar alcohols such as arabinose, glucose, fructose, ribose, mannose, sucrose, trehalose, lactose, maltose, starches, dex- tran or mannitol.
  • a finely divided pharmaceutically acceptable carrier which is preferably present and may be one or more materials known as carriers in dry powder inhalation compositions, for example saccharides, including monosaccharides, disaccharides, polysaccharides and sugar alcohols such as arabinose, glucose, fructose, ribose, mannose, sucrose, trehalose,
  • the dry powder may be in capsules of gelatine or plastic, or in blisters, for use in a dry powder inhalation device, preferably in dosage units of the ciclesonide together with the carrier in amounts to bring the total weight of powder in each capsule to from 5mg to 50mg.
  • the dry powder may be contained in a reservoir of a multi-dose dry powder inhalation device.
  • Capsules and cartridges of for example gelatin, or blisters of for example laminated aluminium foil, for use in an i nhaler or insulator may be formulated containing a powder mix of the active ingredients and a suitable powder base such as lactose or starch, preferably lactose.
  • the active ingredient is suitably micronised so as to permit inhalation of substantially all of the active ingredients into the lungs upon administration of the dry powder formulation, thus the active ingredient will have a particle size of less than 10O ⁇ m, desirably less than 20 ⁇ m, and preferably in the range 1 to 10 ⁇ m.
  • the solid carrier where present, generally has a maximum particle diameter of 300 ⁇ m, preferably 200 ⁇ m, and conveniently has a mean particle diameter of 40 to 100 ⁇ m, preferably 50 to 75 ⁇ m.
  • the particle size of the active ingredient and that of a solid carrier where present in dry powder compositions can be reduced to the desired level by conventional methods, for example by grinding in an air-jet mill, ball mill or vibrator mill, mi- croprecipitation, spray drying, lyophilisation or recrystallisation from supercritical media.
  • the inhalation device may be, for example a dry powder inhalation device adapted to deliver dry powder from a capsule or blister containing a dosage unit of the dry powder or a multi-dose dry powder inhalation device.
  • dry powder inhalation devices are known in the art. Examples which may be mentioned are Cyclohaler®, Diskhaler® Rotadisk®, Turbohaler® or the dry powder inhalation devices disclosed EP 0 505321, EP 407028, EP 650410, EP 691865 or EP 725725 (Ultrahaler®).
  • Formulations for inhalation by nebulization may be formulated with an aqueous vehicle with the addition of agents such as acid or alkali, buffer salts, isotonicity adjusting agents or antimicrobials. They may be sterilised by filtration or heating in an autoclave. Suitable technologies for this type of administration are known in the art. As an example the Mystic® technology is to be mentioned (see for example US6397838, US6454193 and US6302331).
  • Preferred unit dosage formulations are those containing a pharmaceutical effective dose, as hereinbefore recited, or an appropriate fraction thereof, of the active ingredient.
  • a pharmaceutical effective dose as hereinbefore recited, or an appropriate fraction thereof, of the active ingredient.
  • one actuation of the aerosol may deliver half of the therapeutical effective amount such that two actuations are necessary to deliver the therapeutically effective dose.
  • ciclesonide for the manufacture of a medicament for the treatment of a respiratory disease in a smoking patient.
  • formulations of this invention may include other agents conventional in the art having regard to the type of formulation in question.
  • claimed formulations include bioequivalents as defined by the US Food and Drugs Agency.
  • Example 1 Ciclesonide Metered Dose Inhaler (HFA-MDI)
  • Ciclesonide is provided as pharmaceutical product comprising an aerosol vial equipped with a dispensing valve and containing the following formulation:
  • Table 1 Shows the effect on ex-smokers (CIC refers to the ciclesonide treatment, BUD refers to the budesonide treatment). ex smokers, ITT, al values as LSmeans CIC BUD start end start end

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Otolaryngology (AREA)
  • Immunology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)

Abstract

Cette invention concerne un nouveau procédé de traitement des maladies respiratoires, en particulier pour traiter des patients fumeurs asthmatiques. Ce procédé consiste à leur administrer une composition pharmaceutique comprenant du ciclésonide.
PCT/EP2005/051718 2004-04-20 2005-04-19 Utilisation de ciclesonide pour le traitement des maladies respiratoires chez des patients fumeurs WO2005102354A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2007508906A JP2007533706A (ja) 2004-04-20 2005-04-19 喫煙患者における呼吸器疾患の治療のためのシクレソニドの使用
US11/578,294 US20070134165A1 (en) 2004-04-20 2005-04-19 Use of Ciclesonide for the Treatment of Respiratory Disease in a Smoking Patient
CA2563556A CA2563556C (fr) 2004-04-20 2005-04-19 Utilisation de ciclesonide pour le traitement des maladies respiratoires chez des patients fumeurs
AU2005235384A AU2005235384B2 (en) 2004-04-20 2005-04-19 Use of ciclesonide for the treatment of respiratory diseases in a smoking patient
EP05742781A EP1740188A1 (fr) 2004-04-20 2005-04-19 Utilisation de ciclesonide pour le traitement des maladies respiratoires chez des patients fumeurs

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US56346404P 2004-04-20 2004-04-20
US60/563,464 2004-04-20

Publications (1)

Publication Number Publication Date
WO2005102354A1 true WO2005102354A1 (fr) 2005-11-03

Family

ID=34967481

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2005/051718 WO2005102354A1 (fr) 2004-04-20 2005-04-19 Utilisation de ciclesonide pour le traitement des maladies respiratoires chez des patients fumeurs

Country Status (6)

Country Link
US (1) US20070134165A1 (fr)
EP (1) EP1740188A1 (fr)
JP (1) JP2007533706A (fr)
AU (1) AU2005235384B2 (fr)
CA (1) CA2563556C (fr)
WO (1) WO2005102354A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2012296880A1 (en) 2011-08-18 2014-03-27 Astrazeneca Ab Pharmaceutical aerosol product for administration by oral or nasal inhalation
NZ706573A (en) 2012-12-21 2019-11-29 Boehringer Ingelheim Vetmedica Gmbh Ciclesonide for the treatment of airway disease in horses
LT2934544T (lt) * 2012-12-21 2019-02-25 Boehringer Ingelheim Vetmedica Gmbh Farmacinė kompozicija, apimanti ciklezonidą
KR102618119B1 (ko) 2014-06-18 2023-12-27 베링거잉겔하임베트메디카게엠베하 말의 기도 질환의 치료를 위한 무스카린 길항제 및 이의 병용물

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999053926A1 (fr) * 1998-04-20 1999-10-28 Astrazeneca Ab Utilisation d'un glucocorticosteroide dans la preparation d'un medicament permettant de traiter les formes legeres/precoces de bpco (bronchopneumopathie chronique obstructive)

Family Cites Families (47)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3166396D1 (en) * 1980-02-27 1984-11-08 Tate & Lyle Plc Crystalline glucose and process for its production
US4816445A (en) * 1984-06-21 1989-03-28 Kabushiki Kaisha Hayashibara Seibutsu Kagaku Kenkyujo Crystalline alpha-maltose
JP2518646B2 (ja) * 1987-05-29 1996-07-24 株式会社 林原生物化学研究所 マルト−ス粉末の製造方法
US5133974A (en) * 1989-05-05 1992-07-28 Kv Pharmaceutical Company Extended release pharmaceutical formulations
US6536427B2 (en) * 1990-03-02 2003-03-25 Glaxo Group Limited Inhalation device
US5178866A (en) * 1990-03-23 1993-01-12 Alza Corporation Dosage form for delivering drug to the intestine
GR1001529B (el) * 1990-09-07 1994-03-31 Elmuquimica Farm Sl Μέ?οδος για την λήψη νέων 21-εστέρων της 16-17-ακετάλης της πρ να-1,4-διενο-3,20-διόνης.
US5434304A (en) * 1990-09-26 1995-07-18 Aktiebolaget Astra Process for preparing formoterol and related compounds
AU650953B2 (en) * 1991-03-21 1994-07-07 Novartis Ag Inhaler
US6866839B2 (en) * 1991-04-05 2005-03-15 Sepracor Inc. Methods and compositions for treating pulmonary disorders using optically pure (R,R)-formoterol
US5795564A (en) * 1991-04-05 1998-08-18 Sepracor, Inc. Methods and compositions for treating pulmonary disorders using optically pure (R,R)-formoterol
PT656207E (pt) * 1991-06-10 2001-11-30 Schering Corp Formulacoes de aerossois sem clorofluorocarbonetos
IT1250691B (it) * 1991-07-22 1995-04-21 Giancarlo Santus Composizioni terapeutiche per somministrazione intranasale comprendenti ketorolac.
NZ265054A (en) * 1993-04-02 1997-08-22 Byk Gulden Lomberg Chem Fab 16-hydroxy prednisolone cyclohexanecarboxaldehyde acetal derivatives
US5811388A (en) * 1995-06-07 1998-09-22 Cibus Pharmaceutical, Inc. Delivery of drugs to the lower GI tract
US6136839A (en) * 1995-06-12 2000-10-24 G. D. Searle & Co. Treatment of inflammation and inflammation-related disorders with a combination of a cyclooxygenase-2 inhibitor and a 5-lipoxygenase inhibitor
WO1997011705A1 (fr) * 1995-09-26 1997-04-03 Takeda Chemical Industries, Ltd. Phosphorylamides, leur preparation et leur utilisation
US6380222B2 (en) * 1996-10-11 2002-04-30 Astrazeneca Ab Use of an H+, K+-atpase inhibitor in the treatment of nasal polyps
FR2754712B1 (fr) * 1996-10-17 1999-09-03 Merck Sharp Dohme Chibret Lab Compositions ophtalmiques
US6613795B2 (en) * 1996-11-11 2003-09-02 Christian Noe Enantiomerically pure basic arylcycloalkylhydroxycarboxylic esters, processes for their preparation and their use in medicaments
SE9700135D0 (sv) * 1997-01-20 1997-01-20 Astra Ab New formulation
US20020111495A1 (en) * 1997-04-04 2002-08-15 Pfizer Inc. Nicotinamide acids, amides, and their mimetics active as inhibitors of PDE4 isozymes
US6120752A (en) * 1997-05-21 2000-09-19 3M Innovative Properties Company Medicinal aerosol products containing formulations of ciclesonide and related steroids
GB2329939A (en) * 1997-06-26 1999-04-07 Glaxo Group Ltd Self-lubricating valve stem for aerosol containers
SE9704186D0 (sv) * 1997-11-14 1997-11-14 Astra Ab New composition of matter
DE69839735D1 (de) * 1997-12-15 2008-08-28 Astellas Pharma Inc Pyrimidin-5-carboxamid-derivate
TWI243687B (en) * 1998-04-21 2005-11-21 Teijin Ltd Pharmaceutical composition for application to mucosa
US6264923B1 (en) * 1998-05-13 2001-07-24 3M Innovative Properties Company Medicinal aerosol formulation of ciclesonide and related compounds
US6241969B1 (en) * 1998-06-26 2001-06-05 Elan Corporation Plc Aqueous compositions containing corticosteroids for nasal and pulmonary delivery
ATE283033T1 (de) * 1998-07-24 2004-12-15 Jago Res Ag Medizinische aerosolformulierungen
EP1102579B1 (fr) * 1998-08-04 2003-03-19 Jago Research Ag Formulations d'aerosol a usage medical
PT1283036E (pt) * 1998-11-13 2008-03-06 Jagotec Ag Inalador de pó seco de dose múltipla com um reservatório de pó
US6397838B1 (en) * 1998-12-23 2002-06-04 Battelle Pulmonary Therapeutics, Inc. Pulmonary aerosol delivery device and method
US6124268A (en) * 1999-02-17 2000-09-26 Natreon Inc. Natural antioxidant compositions, method for obtaining same and cosmetic, pharmaceutical and nutritional formulations thereof
US6302331B1 (en) * 1999-04-23 2001-10-16 Battelle Pulmonary Therapeutics, Inc. Directionally controlled EHD aerosol sprayer
WO2000064591A1 (fr) * 1999-04-23 2000-11-02 Battelle Memorial Institute Electropulverisateur a transfert de masse eleve
AR026072A1 (es) * 1999-10-20 2002-12-26 Nycomed Gmbh Composicion farmaceutica que contiene ciclesonida para aplicacion a la mucosa
US20020183292A1 (en) * 2000-10-31 2002-12-05 Michel Pairet Pharmaceutical compositions based on anticholinergics and corticosteroids
DE10062712A1 (de) * 2000-12-15 2002-06-20 Boehringer Ingelheim Pharma Neue Arzneimittelkompositionen auf der Basis von Anticholinergika und Corticosteroiden
WO2002038155A1 (fr) * 2000-11-07 2002-05-16 Merck & Co., Inc. Procede de traitement au moyen d'une combinaison d'un inhibiteur de pde4 et d'un antagoniste de leucotriene
IL156308A0 (en) * 2000-12-22 2004-01-04 Glaxo Group Ltd Metered dose inhaler for salmeterol xinafoate
CA2464250C (fr) * 2001-10-24 2008-08-05 Frank-Christophe Lintz Trousse de preparation de composition pharmaceutique
EP1453743B1 (fr) * 2001-11-17 2008-07-23 Aventis Pharma Limited Produit et method pharmaceutiques utilisant un adsorbant
CA2467652A1 (fr) * 2001-11-19 2003-05-30 Altana Pharma Ag Agents utiles pour le traitement des troubles des voies aeriennes
ITMI20020808A1 (it) * 2002-04-17 2003-10-17 Chiesi Farma Spa Procedimento per la preparazione di una sospensione sterile di particelle di beclometasone dipropionato da somministrare per inalazione
BRPI0312377A8 (pt) * 2002-07-02 2015-12-15 Altana Pharma Ag Suspensão aquosa estéril contendo ciclesonida
CA2538419C (fr) * 2003-09-16 2012-07-03 Altana Pharma Ag Utilisation de ciclesonide dans le traitement de maladies respiratoires

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999053926A1 (fr) * 1998-04-20 1999-10-28 Astrazeneca Ab Utilisation d'un glucocorticosteroide dans la preparation d'un medicament permettant de traiter les formes legeres/precoces de bpco (bronchopneumopathie chronique obstructive)

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
CHAUDHURI REKHA ET AL: "Cigarette smoking impairs the therapeutic response to oral corticosteroids in chronic asthma.", AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, vol. 168, no. 11, 1 December 2003 (2003-12-01), pages 1308 - 1311, XP002337333, ISSN: 1073-449X *
DENT G: "CICLESONIDE", CURRENT OPINION IN INVESTIGATIONAL DRUGS, PHARMAPRESS, US, vol. 3, no. 1, 2002, pages 78 - 83, XP001179540, ISSN: 1472-4472 *
SCHMIDT B M W ET AL: "The new topical steroid ciclesonide is effective in the treatment of allergic rhinitis", JOURNAL OF CLINICAL PHARMACOLOGY, LIPPINCOTT CO, HAGERSTOWN, MD, US, vol. 39, no. 10, October 1999 (1999-10-01), pages 1062 - 1069, XP008024248, ISSN: 0091-2700 *
See also references of EP1740188A1 *

Also Published As

Publication number Publication date
EP1740188A1 (fr) 2007-01-10
US20070134165A1 (en) 2007-06-14
AU2005235384A1 (en) 2005-11-03
JP2007533706A (ja) 2007-11-22
AU2005235384B2 (en) 2010-09-09
CA2563556C (fr) 2013-01-29
CA2563556A1 (fr) 2005-11-03

Similar Documents

Publication Publication Date Title
US20220241297A1 (en) Use of ciclesonide for the treatment of respiratory diseases
CA2477885C (fr) Formulations hfa de beta 2-agonistes a action prolongee de derives de 2(1h)-qiunolinone
US20060293293A1 (en) Salmeterol and ciclesonide combination
US20080027034A1 (en) Ciclesonide and Syk Inhibitor Combination and Method of Use Thereof
US20070185067A1 (en) Ciclesonide and glycopyrronium combination
US8088362B2 (en) Salmeterol superfine formulation
CA2563556C (fr) Utilisation de ciclesonide pour le traitement des maladies respiratoires chez des patients fumeurs

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BW BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE EG ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KM KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NA NI NO NZ OM PG PH PL PT RO RU SC SD SE SG SK SL SM SY TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): BW GH GM KE LS MW MZ NA SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LT LU MC NL PL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
WWE Wipo information: entry into national phase

Ref document number: 2007508906

Country of ref document: JP

WWE Wipo information: entry into national phase

Ref document number: 2563556

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 2005742781

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: DE

WWW Wipo information: withdrawn in national office

Country of ref document: DE

WWE Wipo information: entry into national phase

Ref document number: 2007134165

Country of ref document: US

Ref document number: 11578294

Country of ref document: US

WWE Wipo information: entry into national phase

Ref document number: 2005235384

Country of ref document: AU

ENP Entry into the national phase

Ref document number: 2005235384

Country of ref document: AU

Date of ref document: 20050419

Kind code of ref document: A

WWP Wipo information: published in national office

Ref document number: 2005235384

Country of ref document: AU

WWP Wipo information: published in national office

Ref document number: 2005742781

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 11578294

Country of ref document: US